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SUNFIT TH

SOC ETUDES RECHERCHES FABRICATION · Model SUNFIT TH 69 · UDI-DI 03662200005512

MEH LZO Prescription

510(k) clearances

10,185

Adverse events (13 deaths)

196

Recalls

189

Facilities

Description

NOVAE Dual Mobility Acetabular Cup - SUNFIT TH metal-back cementless SUNFIT TH version is available without the pegs and screw, and is a press fit only

Recalls

Date	Firm	Reason
2025-09-11	Theken Companies LLC	Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
2022-08-11	Exactech, Inc.	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
2021-07-28	Corin Ltd	The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.